As the 2018 midterm elections approach and the 115th Congress draws to a close, it is important for pharmacists to stay informed on legislative and regulatory issues that have the potential to affect their practice.
As the 2018 midterm elections approach and the 115th Congress draws to a close, it is important for pharmacists to stay informed on legislative and regulatory issues that have the potential to affect their practice, according to the American Society of Health-System Pharmacists (ASHP).
During a presentation at the 2018 ASHP Summer Meetings and Exhibition in Denver, Colorado, members of ASHP’s government relations division provided updates on a number of key pharmacy-related public policy issues, including:
1. Provider Status
Provider status continues to be a top legislative goal for pharmacists, with pharmacy advocates championing efforts to achieve it at both the federal and state level.
In the federal arena, the Pharmacy and Medically Underserved Areas Enhancement Act—which would allowing pharmacists to receive Medicare Part B reimbursement for services provided to underserved populations—was reintroduced to both the Senate (S 109) and the House of Representatives (HR 592) in January 2017.
However, ASHP federal legislative affairs director Christopher Topoleski explained that much of the 115th Congress spent much of 2017 deliberating over the potential repeal and replace of the Affordable Care Act; as a result, other health care legislation failed to move. Topoleski further suggested that, with Congress turning its attention to the midterm elections in November, there would be limited opportunities for health care legislation for the remainder of the year.
Fortunately, Nicholas Gentile, the director of state grassroots advocacy and political action for ASHP, added that provider status has gained ground in several states through proposed legislation. In New York, the Comprehensive Medication Management Bill (SB7682) would allow pharmacists to enter into comprehensive medication management protocols and adjust their patients’ drug regimens. In Ohio, the Provider Status Bill (SB 265) would add pharmacists to provider lists in multiple places in statute, enabling them to be reimbursed for certain services.
2. Drug Shortages
Drug shortages were a notable concern among session attendees, with a vast majority raising their hands after being asked if their pharmacy practice had been impacted by shortages. Common medications affected by shortages include sodium bicarbonate, epinephrine, morphine, and hydromorphone.
Topoleski stated that advocacy groups have been working with agencies such as the FDA and the US Department of Health and Human Services (HHS) to address drug shortages and reopen dialogue about the issue with Congress.
3. Drug Prices
Rising drugs costs have been the focus of considerable Congressional attention over the past year, Topoleski said, with legislators introducing over 20 bills intended to curb prices in the House and Senate to date.
Topoleski highlighted several such bills supported by ASHP, including the Creating and Restoring Equal Access to Equivalent Samples Act of 2017 (HR 2212/S 124), which would reduce the ability of brand-name medication to manipulate the market, as well as the Preserve Access to Affordable Generics Act (S 124) and the Increasing Competition in Pharmaceutical Act (S 297), both of which increase competition by prohibiting “pay to delay” tactics and expediting reviews of generic drugs.
4. Opioid Abuse
In response to the growing opioid abuse epidemic, the House Energy and Commerce Committee’s Subcommittee on Health has held numerous hearings in which a total of 65 possible bills were discussed, Topoleski explained.
In the Senate, efforts have been made to build upon the Comprehensive Addiction and Recovery Act of 2016, which included pharmacists on a federal task force intended to combat opioid abuse though education and treatment rather than criminal prosecution.
ASHP federal regulatory affairs director Jillanne Schulte-Wall, JD, noted that the FDA has addressed through multiple efforts, including the release of a draft guidance on developing buprenorphine depot products.
5. 340B Reform
The 340B Drug Discount Program has been a focus of recent Congressional attention, according to ASHP government relations director Joseph Hill.
In July 2017 and October 2017, the House Energy and Commerce Committee held hearings on the 340B program to discuss concerns about Health Resources and Services Administration (HRSA) regulatory authority and the program’s use by covered entities. The committee released a report in January 2018 calling for changes to the program such as independent audits, fewer duplicate discounts with Medicaid, and greater transparency.
Legislative efforts to reform the 340B program are underway, Hill added, though such proposals have taken diverse approaches.
Additionally, Schulte-Wall stated that a final rule to implement 340B drug pricing rules and civil monetary penalties had been further delayed by the HRSA in May 2018.
Hill emphasized that any reforms to the 340B program should ensures its long-term protection.